Apparatus and methods for IOL insertion

ABSTRACT

Apparatus for inserting intraocular lenses (IOLs) into eyes include a tube, an elongated member having a tip secured to its distal end, and a rod having a distal end portion. Methods for inserting an IOL into an eye using such apparatus are within the scope of the present invention.

BACKGROUND OF THE INVENTION

The present invention relates to apparatus and methods for inserting anintraocular lens into an eye. More particularly, the invention relatesto such apparatus and methods wherein the desired insertion of the lensis easily, controllably and effectively achieved.

An intraocular lens (IOL) is implanted in the eye, for example, as areplacement for the natural crystalline lens after cataract surgery orto alter the optical properties of (provide vision correction to) an eyein which the natural lens remains. IOLs often include an optic, andpreferably at least one flexible fixation member or haptic, whichextends from the optic and becomes affixed in the eye to secure the lensin position. The optic of the IOL normally includes an optically clearlens. Implantation of such IOLs into the eye involves making an incisionin the eye. Making the incision as small as possible reduces trauma andspeeds healing.

IOLs are known which are foldable (deformable) so that the IOL can beinserted into the eye through an incision smaller than the diameter ofthe lens and subsequently permitted to unfold after it has passedthrough the incision. A substantial number of instruments have beendevised to aid in inserting such a foldable lens into the eye. Theadvantages of the foldable lens in cataract removal and lens replacementare so significant that many of the lens replacement procedures areperformed with folded lenses inserted into the eye, and released thereinto assume their initial unfolded state.

Some of the most generally accepted insertion apparatus employ a hollowinsertion tube having a diameter which permits the folded IOL to passthrough the hollow space defined by the tube without permanentdeformation, and a plunger assembly including a rod, often made ofmetal, which is moved longitudinally in the hollow space in contact withthe optic of the IOL to push the IOL through the hollow space.

Several disadvantages are apparent in such insertion devices. Forexample, pushing, without trapping or holding, the IOL through and outof the hollow space defined by the tube can cause the IOL to be releasedfrom the insertion device without precise control, so that the releasedIOL may damage the eye and/or may be mispositioned in the eye. Inaddition, the metal rod can result in marking the surface of the opticand/or even tearing the optic, particularly when the optic is made ofsoft materials, such as soft elastomeric silicone polymeric materials.Also, the metal rod has a tendency to by-pass the IOL in the hollowspace. That is, the rod as it is being moved distally through the hollowspace may actually pass through a fold in the folded optic. If thisoccurs, the rod becomes ineffective to push the IOL through the hollowspace. This problem has been avoided in the past by increasing thecross-sectional area of the rod. However, a rod with a largecross-sectional area presents its own problems. For example, pushingsuch a large rod through the hollow space can damage the IOL and/or theinserter or result in an uncontrolled release of the IOL into the eye,possibly with inserter debris being disadvantageously introduced intothe eye.

Stoy et al U.S. Pat. No. 4,919,130 discloses a rod-type IOL insertiondevice including two separate rods. This patent discloses a cup-shapedhead of soft material, such as a silicone elastomer, detachablyconnected at the distal end of the second rod which pushes a compressedIOL through the cannula or tube. Although this cup-shaped head may avoidscratching or tearing the lens during the pushing operation, itscup-shaped distal face does nothing to increase the control the surgeonhas in releasing the IOL in the eye. In addition, this cup-shaped headis relatively short, in the axial direction, which can result in thehead becoming separated from the rod in the eye. This can result in anadditional procedure to remove the head from the eye, which is traumaticfor the patient.

One further disadvantage of using a soft head or tip is the need toplace the head or tip on the rod and then to remove it, for example,after use for disposal. Because such heads tend to be relatively small,it is often difficult and time and labor consuming to apply the head tothe rod manually and to remove the head from the rod manually.

The disclosure of commonly assigned U.S. patent application Ser. No.08/592,753 filed on even date herewith is incorporated by reference inits entirety herein.

It would be advantageous to provide IOL insertion apparatus and methodswhich facilitate the use of soft heads or tips to enhance the advantagesof using such soft heads or tips on the rods of IOL insertion apparatus.

SUMMARY OF INVENTION

New apparatus for inserting IOLs and methods for inserting IOLs intoeyes have been discovered. The present apparatus and methods solve oneor more of the problems of the prior art systems, such as those problemsnoted above. The present apparatus enable the surgeon to effectively andefficiently achieve a desired degree of control as the IOL is releasedfrom the apparatus, while, at the same time, making it easier and lesstime and labor consuming to do so. The present invention isstraightforward, easy to make and practice and involves little or nomodification of existing surgical techniques. Also, the IOLs do not needto be modified to accommodate the present apparatus and methods.

In one broad aspect, the present invention comprises apparatus forinserting IOLs into an eye which include a tube defining a hollowpassage, for example, through at least a portion of which a folded IOLcan be moved. This tube has a port, preferably at its distal end,through which the IOL is passed from the hollow passage into an eye. Anelongated member is provided which is longitudinally movable within thehollow space and has a distal end portion and a proximal end portion. Arod is also included, is longitudinally movable and has a distal endregion which is coupled, preferably removably coupled, to the elongatedmember, for example, at the proximal end region of the elongated member.A tip is secured, preferably permanently secured, to the elongatedmember and extends distally from the distal end portion of the elongatedmember. This tip is softer, and preferably more elastic, than the distalend portion and is sized and configured so that at least a portion ofthe tip comes in contact with the folded IOL as the elongated member ismoved distally in the hollow space. The rod and the elongated member maybe made of metal, a relatively rigid or non-elastic polymeric materialor combinations thereof. The elongated member preferably is made ofpolymeric material.

Preferably, the elongated member is made of a first polymeric materialand the tip is made of a different, second polymeric material. Theelongated member is preferably at least somewhat rigid, for example,more rigid then the tip, to allow effective transfer of forces from therod to the tip.

Any suitable method may be employed to produce the tip/elongated membercombination. One very useful production method is insert molding. Forexample, the elongated member can be formed and then included in a moldin which the tip is formed onto the distal end portion of the elongatedmember, for example, using conventional insert molding techniques. Theelongated member preferably includes at least one through hole and aportion of the tip is located in this through hole, thereby facilitatingthe permanent securement of the tip to the elongated member.

In one embodiment, the elongated member defines a cavity, preferablyincludes a plurality of elements defining a cavity, in which the distalend region of the rod is maintained. More preferably, the plurality ofelements and the distal end region of the rod are configured tofacilitate the distal end region passing into the cavity as the rod ismoved longitudinally toward the elongated member and to resist thedistal end region passing out of the cavity as the rod is movedlongitudinally away from the elongated member. For example, theplurality of elements may be adapted to flex as the distal end region ispassed distally into the cavity. The distal end region of the rod may beinterference-fitted or friction-fitted into the cavity. Still further,the distal end region of the rod may be threaded and the elongatedmember may include threads, for example, on the inner sidewall of thecavity, which matingly engage the distal end region of the rod.

In any event, the rod is coupled to the elongated member.

In another broad aspect of the present invention, apparatus for holdinga folded IOL prior to insertion in an eye are provided. Such apparatuscomprise a tube and a tip holder. The tube defines a hollow space inwhich a folded IOL is maintained prior to insertion in an eye. The tubehas a port through which the IOL is passed from the hollow space into aneye. The tip holder is positioned proximally of the hollow space and isadapted to hold a tip prior to the tip being carried by a rod which islongitudinally moveable within the hollow space.

In this aspect of the invention, the tip is preferably picked up by therod as the rod is moved distally toward the hollow space. Morepreferably, the tip is removed from the rod as the rod moves proximallyaway from the hollow space.

The tip holder preferably defines a through space substantially alignedwith the hollow space and through which the rod passes prior to enteringinto the hollow space. The tip holder is preferably adapted to resistthe tip separating from the tip holder as the rod is moved distally intothe through space. More preferably, the tip holder is adapted tofacilitate the removal of the tip from the rod as the rod is movedproximally away from the hollow space. For example, the tip holder mayinclude a lip extending into the through space which is adapted toremove the tip from the rod as the rod is moved proximally from thehollow space.

In one very useful embodiment, the tube and tip holder combinationfurther comprises a tip held by the tip holder.

IOL loading cartridges including the tube and the tip holder inaccordance with the present invention, can be manufactured, for example,molded as an integral unit. This unit, which is preferably made ofsubstantially rigid polymeric material, can be very effectively used,for example, in conjunction with a rod and hand piece, and then disposedof in a cost effective manner.

The tip in accordance with the present invention may be of any suitableconfiguration, provided that it functions as described herein. The tippreferably has a configuration such that (1) at least a portion of thetip is trapped or held by the IOL (the IOL may be considered to betrapped by the tip); and/or (2) the tip does not bypass the IOL duringthe insertion process; and/or (3) the tip does not cause significant orundue damage to the IOL. More preferably, at least two of these criteriaare met, and still more preferably all three of the criteria are met.

The tip is preferably made of a polymeric material, particularly anelastomeric polymeric material, such as an elastomeric siliconepolymeric material.

In one very useful embodiment, the tip is sized and configured so thatat least a portion of the tip is introduced into a fold of the foldedIOL as the elongated member and/or the rod is moved distally in thehollow space. More preferably, the tip is sized and configured so thatat least a portion of the tip is held or trapped in a fold of the foldedIOL as the elongated member and/or the rod is moved distally in thehollow space. These features of the present invention preferably resultin the folded IOL being passed through the hollow space of the tubeother than by pushing, even through the elongated member and/or the rodand the tip are being moved distally. The folded IOL can be consideredas being carried by and/or pulled by the elongated member and/or therod/tip combination. The advantage of this non-pushing mode of passingthe IOL through the hollow space is increased control. That is, thesurgeon has an increased degree of control, relative to pushing the IOLthrough the hollow passage, of the movement of the IOL through thehollow passage of the tube and the release of the IOL into the eye.

If an elongated member is employed, the present tip is secured,preferably permanently secured, to the elongated member. Since theelongated member preferably has sufficient length to allow easy andrapid coupling to the rod, having the tip secured, preferablypermanently secured, to the elongated member greatly facilitatesincluding the tip in the present system. Also, since it is preferredthat the tip be disposed of after a single use, and, while much of theremainder of the present system is made of metal and can be reused aftersterilization, the use of the elongated member/tip combination is veryeffective for rapid changing of the tip.

The tip preferably has a proximal end segment having an outer surfacewhich defines a cross-sectional area which is larger than thecross-sectional area defined by the outer surface of any other segmentof the tip. The proximal end segment of the tip preferably is larger incross-sectional area than is the distal end segment of the tip. Thisfeature, which may be considered to be a distal tapering of the tip,allows the tip to more effectively and efficiently enter a fold of theIOL and to become held or trapped by the folded IOL. A particularlyuseful embodiment provides that the distal end segment defines a smallercross-sectional area than does that defined by the outer surface of theproximal end of the tip. Very effective results are obtained byproviding the tip with a proximal end segment which is substantiallytapered. For example, at least a portion of the tip which extendsdistally beyond the elongated member and/or the rod may have a generallyconical or truncated conical configuration which facilitates theintroduction of the tip into a fold of the folded IOL.

The tip of the present apparatus preferably is itself sufficientlyelongated so that when the tip is being held in a fold of the folded IOLthe optic of the IOL is not in direct contact with the elongated memberand/or the rod. That is, for example, the tip has sufficient length sothat the optic of the folded IOL comes in direct contact only with thetip as the elongated member and/or the rod is moved distally in thehollow space defined by the tube. This feature provides substantialbenefits, for example, in that the optic is prevented from contactingthe elongated member and/or the rod, which may cause scratching ortearing of the optic. Excellent results are obtained with a tip having alength in the range of about 1 mm to about 5 mm or 10 mm or about 50 mm,although other lengths may be suitable. In one embodiment, the proximalend segment of the tip is longer than all the other segments of the tipcombined.

In another broad aspect of the present invention, methods for insertingan IOL into an eye are provided. These methods comprise placing an IOLin a folded condition in the tube/tip holder/tip-containing apparatusdescribed herein; moving a rod distally relative to the tip holder toposition the tip on the rod; moving the rod further distally into thehollow space defined by the tube, thereby contacting the tip and theIOL; positioning the port of the tube in proximity to or in the eye;passing the IOL through the hollow space, through the port and into theeye; passing the rod proximally; and removing the tip from the rod. Thepositioning of the tip on the rod and the removing of the tip from therod preferably occur substantially automatically, for example, simply bymoving the rod distally into the hollow space and then moving the rodproximally out of the hollow space.

An important advantage of the present methods is that the IOL can bepassed into the eye through an incision in the eye no larger than about3.5 mm, more preferably no larger than about 3.0 mm. Also, because thetip preferably is "automatically" positioned on the rod and removed fromthe rod, as desired, the tedious task of manually applying and removingthe tip from the rod is eliminated. This facilitates the use of the tip,and more conveniently allows the attainment of the benefits of the tip.Also, since the tip is removed after use, much of the remainder of theapparatus, for example, the rod and the hand piece, can be sterilizedand reused repeatedly.

Each of the individual features of the present invention disclosedherein may be used alone or in combination with one or more other ofsuch features, provided such features are not mutually consistent witheach other. All apparatus and methods involving any such feature orcombination of such features are included within the scope of thepresent invention.

These and other aspects of the present invention will become apparent inthe following detailed description and claims, particularly whenconsidered in conjunction with the accompanying drawings in which likeparts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side perspective view of an insertion apparatus inaccordance with the present invention.

FIG. 2 is a side view, partly in cross-section, of the rod-plungerassembly removed from the body of the insertion apparatus shown in FIG.1.

FIG. 3 is a side view, partly in cross-section, of the area within thearc 3 of FIG. 2.

FIG. 4 is a view, partly in cross-section, taken generally along line4--4 of FIG. 3.

FIG. 5 is a view taken generally along line 5--5 of FIG. 4.

FIG. 6 is a side view, partly in cross-section, of the area within thearc 6 of FIG. 2 showing the coupling of the rod and elongated member.

FIG. 7 is a cross-sectional view taken generally along lines 7--7 ofFIG. 6.

FIG. 8 is a cross-sectional view showing an alternate assembly couplingthe rod and the elongated member.

FIG. 9 is a cross-sectional view taken generally along line 9--9 of FIG.8.

FIG. 10 is a cross-sectional view showing another assembly coupling therod to the elongated member.

FIG. 11 is a side elevation view, partly in cross-section, of theinsertion apparatus shown in FIG. 1 with the tip introduced into a foldof the IOL to be inserted into an eye.

FIG. 12 is a perspective view of a folding device shown in the openposition.

FIG. 13 is a schematic perspective view showing the placement of thedistal portion of the insertion tube in an eye.

FIG. 14 is a perspective view of an alternate folding device shown inthe open position.

FIG. 15 is a side view, partly in cross-section, of an alternate tip.

FIG. 16 to 19 are a series of views, partly in cross-section, of theproximal portion of the alternate folding device shown in FIG. 14, inthe closed position. Each of these Figs. show the rod and/or alternatetip at different locations in the process of using the alternate foldingdevice to insert an IOL into an eye.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates an IOL insertion apparatus, shown generally as 10.The apparatus 10 comprises body 21, and a loading cartridge 13 includinga forward tube 11 having an open port 12 at its distal end. The body 21of injection apparatus 10 is an integrally formed unit. Loadingcartridge 13 has folding leaves 14 and 15 which extend through opening17 in the outer wall of the body 21. Proximal end portion 18 can besized to completely and closely encompass plunger 19 of rod-plungerassembly 30, which has a plunger cap 20 affixed to its proximal end.

Proximal end portion 18 is hollow and includes a threaded surface 22,the threads of which matingly engage the threads 24 on the outer surfaceof plunger 19.

Insertion apparatus 10 includes a slot 23 which extends from theproximal portion of opening 17 and connects therewith. Slot 23 iselongated in a direction parallel to the longitudinal axis of insertionapparatus 10. Slot 23 is sufficiently wide to permit the closed foldingmembers 51 and 52, shown in FIG. 12, to fit therethrough, andsufficiently long to permit loading cartridge 13 to be inserted therein,so that the loading cartridge can be subsequently moved into connectingopening 17, which is sufficiently narrow to hold the folding cartridgein a fully closed position.

As shown in FIG. 11, the distal end portion 25 of body 21 is hollow.When loading cartridge 13 is inserted into body 21, as shown in FIG. 11,the hollow space defined by the inner wall 27 of the body 21 is alignedwith the hollow space 29 defined by the inner wall 31 of the loadingcartridge 13. The combination of the joined body 21 and cartridge 13 canbe considered a hollow tubular member defining a hollow space throughwhich the elongated member can pass longitudinally.

FIG. 2 shows injector rod-plunger assembly 30 with locking enclosure 32aholding injector rod cap 32. Tip 34 is disposed on the distal end region37 (FIG. 3) of the elongated member 35. Tip 34 is made of an elastomericsilicone polymer composition which is softer and more elastic than rod33, which is made of titanium, and elongated member 35, which is made ofa relatively polymeric material, such as reinforced polyamide, liquidcrystal polymer and the like. For example, tip 34 is made of a materialhaving a Shore A Hardness value in the range of about 40 to about 80 orabout 90 or higher, more specifically about 70 to about 75. Viewed froma different perspective, the tip 34 preferably has a Shore A Hardnessvalue within about 30 of the Shore A Hardness value of the material forwhich the optic of the IOL to be inserted is made.

With reference to FIG. 3, tip 34 has a length in the range of about 2 mmor about 5 mm to about 25 mm or about 50 mm, for example, about 10 mm.The length of tip 34 beyond the distal end 36 of elongated member 35 isin the range of about 0.25 mm to about 1.0 mm, for example, about 0.75mm. Tip 34 is generally tapered in the distal direction, with theproximal end region 42 having an outer surface 44 which defines a largercross-sectional area (transverse to longitudinal axis 46) than any otherregion of the tip. In addition, the distal end region 48 has an outersurface 50 (which extends to the distal end 52 of tip 34) which definesa smaller cross-sectional area than that defined by the outer surface 44of the proximal end region 42. The outer surface of the tip 34preferably is configured to facilitate holding or trapping of at least aportion of the tip in the IOL.

Elongated member 35 is sized and adapted to facilitate applying, forexample, manually applying, the tip 34 to the plunger/rod assembly 30.The elongated member 35 preferably has sufficient length so as to beconveniently held in the hand of a human as the elongated member isbeing coupled to the rod 33. Particularly useful are elongated membershaving lengths in the range of about 0.5 cm or about 1 cm to about 5 cmor about 10 cm or longer.

The combination of tip 34 and elongated member 35 is preferablydisposable after a single use, that is after being used to insert asingle IOL into an eye. The other components of the IOL insertionapparatus 10, except for loading cartridge 13, are constructed, forexample, of metal, so as to be reusable after sterilization.

The tip/elongated member combination can be made in any suitable manner,provided that the tip 34 is secured to the elongated member 35 and thatboth components and the combination function as described herein. In oneparticularly useful embodiment, the elongated member 35 is molded, forexample, using conventional techniques, into the desired form and size.Preferably, the elongated member 35 includes a through hole 39 locatedin the distal end region 37. Once the elongated member 35 is formed, thetip 34 is secured to the distal end region 37, for example, usingconventional insert molding techniques. The precursor material for thetip 34 is sufficiently flowable to fill the through hole 39. When thisprecursor material is cured, for example, using conventional techniques,the tip 34 is secured to the distal end region 34 of elongated member35. The cured material in through hole 39 is part of tip 34 andfacilitates the securing of the tip to the elongated member 35.

The distal end region 48 of tip 34 includes a slotted truncated conestructure 70. A cross slot 72 (FIG. 5) is placed in the truncated conestructure 70. This feature facilitates introducing the tip 34 into afold of an IOL as the elongated member and tip combination is moveddistally in the hollow space of a tube, as is described hereinafter.However, it should be noted that this slot structure 72 and thetruncated cone structure 70 are not necessary in order to achievesubstantial benefits in accordance with the present invention.

Elongated member 35 may be coupled to rod 33 in any suitable manner. Thecoupling between the elongated member 35 and the rod 33 should besufficiently strong or secure so that these two components remain joinedas the IOL insertion apparatus 10 is used to insert an IOL into an eye.For example, with reference to FIGS. 6 and 7 the proximal end region 41of the elongated member 35 defines a hollow chamber 43 which terminatesat end wall 45. Two spaced apart elements 47 and 49 are located near thedistal end of the proximal end region 41. Elements 47 and 49 eachinclude an inwardly extending segment 47a and 49a, respectively, whichnarrow the diameter of hollow chamber 43. Indents 47b and 49b areprovided in elongated member 35 to facilitate a limited degree offlexing of elements 47 and 49, respectively. The distal end portion 36of rod 33 includes a narrowed region 36a, an outwardly extending annularprojection 36b and an intermediate diameter end region 36c.

The rod 33 and elongated member 35 are coupled or joined by passing thedistal end portion 36 into the chamber 43. As the annular projection 36bcomes into contact with segments 47a and 49a, elements 47 and 49 flexoutwardly to allow the projection to pass distally. Once projection 36bis distal of segments 47a and 49a, elements 47 and 49 return to theirnormal positions. In so doing, projection 36b and end region 36c areheld or trapped in the distal end region of the hollow chamber 43. Rod33 is thus coupled or joined to elongated member 35 and is ready foruse. The elements 47 and 49 are configured so that when desired, forexample, after use, the rod 33 and elongated member 35 can be decoupledsimply by pulling, in particular manually pulling, these two componentsapart.

The embodiment illustrated in FIGS. 8 and 9 utilize an interference orfriction fit to couple or join the rod and the elongated member. Exceptas expressly described herein, this embodiment is substantially similarto that illustrated in FIGS. 6 and 7. Corresponding components areindicated by corresponding reference numerals increased by 100.

With reference to FIGS. 8 and 9, spaced apart elements 147 and 149 arepositioned a substantially uniform distance apart along their lengthsterminating at distal end wall 145. This substantially uniform distanceis less than the diameter of the hollow chamber 143 distally of elements147 and 149. The distal most segment 46 of distal end portion 136 of rod133 has a substantially uniform diameter which substantially correspondsin size to the distance between elements 147 and 149. Thus, rod 133 iscoupled or joined to elongated member 135 by passing the rod intochamber 143. As the distal most region 46 passes between elements 147and 149, the distal end portion 136 becomes entrapped. The elements 147and 149 are configured so that when desired the elements can be flexedapart and the rod 133 can be pulled out of chamber 143 to decouple therod and elongated member 135.

The embodiment illustrated in FIG. 10 utilizes a threaded engagement tocouple or join the rod and the elongated member. Except as expresslydescribed herein, this embodiment is substantially similar to thatillustrated in FIGS. 6 and 7. Corresponding components are indicated bycorresponding reference numerals increased by 200.

With reference to FIG. 10, a distal region of the inner wall 48 defininghollow chamber 243 extends further inwardly than the remainder of theinner wall and is threaded. The distal end portion 236 is threaded so asto threadably engage the threads on inner wall 48. Thus, rod 233 iscoupled or joined to elongated member 235 by passing the rod intochamber 243 and threading distal end portion 236 onto inner wall 48.When desired, the rod 233 can be decoupled from elongated member 235simply by unthreading distal end portion 236 from inner wall 48.

FIG. 12 illustrates the manner in which loading cartridge 13 producesthe desired result of folding IOL 57. Hinged folding leaves 14 and 15are used to open and close folding members 51 and 52, respectively. IOL57 (in an unfolded state) is placed on folding members 51 and 52, byforceps 59. The forceps 59 hold the IOL 57 in a specific anddeterminable planar orientation. Superior haptic 61 is placed forward ofoptic 63, while the other haptic 65 trails the optic, as shown in FIG.12. Hinged folding leaves 14 and 15 are moved together, which folds theflexible or foldable optic 63 of IOL 57 in half. After IOL 57 is folded,the forceps 59 is removed.

The closed loading cartridge 13, containing the folded IOL 57, is thenloaded into body 21 of insertion apparatus 10, as described above. Aneffective amount of a lubricant composition, such as a visco-elasticmaterial, for example, a conventional sodium hyaluronate-containingaqueous material, preferably is included in the hollow space defined bythe loading cartridge 13. This lubricant composition allows the foldedIOL 57 to more easily pass through the hollow space defined by loadingcartridge 13.

Insertion apparatus 10 is operated and functions as follows. When it isdesired to insert IOL 57 into an eye, the apparatus 10 is placed in aconfiguration as shown in FIG. 1, with elongated member 35 (with tip 34)secured to rod 33, as shown in FIG. 2.

With the IOL 57 in its folded condition within apparatus 10, theoperator (surgeon) advances plunger 19 distally by rotating cap 20. Thisaction advances rod 33 and elongated member 35 distally. As rod 33 andelongated member 35 are moved distally, the tip 34 comes into contactwith folded optic 63 and is introduced into the fold of the folded opticas shown in FIG. 11. Because of the relative softness and elasticity oftip 34, the distal movement of rod 33 and elongated member 35 causes thetip to become trapped in the fold of the folded optic 63. The foldedoptic 63 can be considered to be pulled or carried by the rod 33,elongated member 35 and tip 34 when the tip is trapped in the fold.

Referring now to FIG. 13, the IOL 57 is to be placed in eye 73 into anarea formerly occupied by the natural lens of the eye. With the IOL 57in its folded position within apparatus 10, and tip 34 trapped in thefold of the folded optic 63, forward tube 11 is ready for insertionthrough an incision in the sclera 75 of eye 73. Capsular bag 74 protectsthe posterior segment of the eye 73. With the forward tube 11 insertedwithin the eye 73 and the port 12 positioned so that the IOL 57 canunfold in the location within the eye 73 best suited for permanentimplantation, the operator advances plunger 19 by rotating cap 20. Thisaction advances rod 33, elongated member 35, tip 34 and IOL 57 distallyinto the forward tube 11.

As rod 33 advances farther distally, the IOL exits the port 12 in acontrolled manner and is controllably released in a location as close aspossible to the IOL's final implanted position.

FIG. 13 shows the sclera 75 having an incision through which the distalend portion of forward tube 11 is passed. Alternately, the incision canbe made through the cornea or other portion of the eye. Forward tube 11has a sufficiently small cross-section to pass into the eye 73 through a3.0 mm incision in the sclera 102. Folding leaves 14 and 15, in contactwith each other when lens loading cartridge 13 is in a closed position,can be grasped by an operator and used to guide and position insertiontube 11 in its desired position within the eye.

After IOL 57 has been inserted into eye 73, forward tube 11 is removedfrom the eye. The tip 34 can be used to position the IOL 57 in the eye.For example, the tip 34 can be retracted (after the optic is released)and then used to push the trailing haptic 65 out of the tube andposition this haptic into the eye. If needed, IOL 57 can be repositionedin the eye by a small, bent needle or similar tool inserted into thesame incision.

Once IOL 57 is properly positioned in eye 73 and apparatus 10 iswithdrawn from the eye, the incision in the sclera may be closed, forexample, using conventional techniques. After use, loading cartridge 13and elongated member 35 (including tip 34) are preferably disposed of.Remaining portions of apparatus 10 can be reused after sterilization anddisinfection.

FIGS. 14 and 16 to 19 show an alternate loading cartridge 313. Except asexpressly described herein loading cartridge 313 is structuredsubstantially similar to loading cartridge 13. Corresponding componentsare indicated by corresponding reference numerals increased by 300.

The primary difference between loading cartridge 313 and loadingcartridge 13 is the presence of proximal member 80. Although proximalmember 80 can be secured to the remainder of loading cartridge 313 inany suitable manner, it is preferred that this proximal member beintegrally formed, for example, molded, with the remainder of theloading cartridge. Proximal member 80 includes a cylindrical component82 which defines a hollow through compartment 83. As can be seen inFIGS. 16 to 19, hollow compartment 83 is aligned with the hollow space329 defined by the inner wall 327 of loading cartridge 313. Inparticular, proximal member 80 is situated adjacent to folding member352 so that when the loading cartridge 313 is placed in the closedposition the hollow through compartment 83 is directly aligned with thehollow space 329 defined by the inner wall 327 of the closed loadingcartridge 313.

Referring now to FIGS. 16 to 19, proximal member 80 includes a distalend opening 86 including an inwardly extending lip 88 which slightlyreduces the size of the distal opening 86. Hollow through compartment 83is sized and adapted to allow tip 90 to be passed distally through thehollow through compartment and to be situated as shown in FIG. 16.Alternately, the tip 90 can be located, for example, during storage,entirely within hollow through compartment 83. The proximal most portion91 of tip 90 is held in hollow through compartment 83 because it has anincreased diameter relative to the outside diameter of distal opening86.

With reference to FIG. 15, tip 90 includes an irregularly shaped innersurface 92 which defines an irregularly shaped blind bore 93 which iscompatible with the shape of the distal end portion 94 of rod 96 (FIGS.16 to 19). The blind bore 93 is open at the proximal end 99 of tip 90.The inner surface 92 is configured to mate with the outer surface 98 ofthe distal end portion 94 of rod 96. Inner surface 92 includes aslightly enlarged flared region 100 which facilitates placing the distalend portion 94 of the rod 96 into the blind bore 93 defined by the innersurface 92. Tip 90 include distal annular indents 101 and 102 which areeffective in facilitating introducing the tip into a fold of a foldedIOL and in facilitating holding the tip in the fold of the IOL. With theouter surface 98 of the distal end portion 94 of rod 96 mated to theinner surface 92 defining the blind bore 93, tip 90 is secured to rod96.

Tip 90 is configured substantially similar to tip 34, with the exceptionthat the distal most portion 91 of tip 90 is substantially shorter thanthe distal most portion of tip 34.

The combination of loading cartridge 313 and tip 90 can be packaged as aunit. Thus, this combination can be manufactured, sterilized andpackaged so as to be ready for use in a single IOL insertion procedure.

The combination of loading cartridge 313 and tip 90 is used as follows.For the purposes of this discussion, rod 96 is secured directly toplunger 19 in a manner similar to the securement between plunger 19 androd 33. In addition, IOL 81 is loaded into loading cartridge 313 in amanner similar to that in which IOL 57 is loaded into loading cartridge13. Once the loading cartridge 313 has been loaded with IOL 81, it isplaced in the body 21 of IOL insertion apparatus 10. An effective amountof a lubricant composition is included in the loading cartridge 313, asdescribed previously. For the sake of clarity, FIGS. 16 to 19 do notshow the body 21.

Referring now to FIGS. 16 to 19 with regard to the operation of loadingcartridge 313, FIG. 16 shows the rod 96 proximally of the loadingcartridge 313 which includes the folded IOL 81. As rod 96 is moveddistally through the hollow through compartment 83 it comes in contactwith tip 90. Because of the mating configurations noted above, thedistal end portion 94 of rod 96 completely fills the blind bore 93defined by inner wall 92. As the rod 96 continues to be moved distally,this movement overcomes the resistance caused by lip 88. Since tip 90 ismade of a elastomeric silicone polymeric material, it is somewhatcompliant so that the distal most portion 91 of tip 90 passes out ofhollow through compartment 83.

With reference to FIG. 18, as rod 96 continues to be moved distally, tip90 is introduced into the fold of folded IOL 81. Rod 96 is moved stillfurther distally to cause the IOL to be passed through the hollow space329 defined by the inner wall 327 of loading cartridge 313 and into theeye. Once the folded IOL 81 has been inserted into the eye, rod 96 ismoved proximally through the hollow space 329 defined by the inner wall327 of loading cartridge 3132 and into and through the hollow throughcompartment 83 of proximal member 80. As shown in FIG. 19, as the distalend portion 94 of rod 96 passes into the hollow through compartment 82,the proximal most portion 91 of tip 90 contacts lip 88. This causes thetip 90 to become separated from rod 96. At this point, since the IOL 81has been inserted, the loading cartridge 313 and tip 90 can be removedfrom the body 21 of apparatus 10 and disposed of, while the remainder ofthe components of apparatus 10 can be sterilized and/or otherwiseprepared for reuse.

While this invention has been described with respect to various specificexamples and embodiments, it is to be understood that the invention isnot limited thereto and that it can be variously practiced within thescope of the following claims.

What is claimed is:
 1. An apparatus for inserting a folded intraocularlens into an eye comprising:a tube defining a hollow passage and havinga port through which the intraocular lens is passed from said hollowpassage into an eye; an elongated member longitudinally provable withinsaid hollow passage and having a distal end portion and a proximal endportion; a rod which is longitudinally movable and has a distal endregion which is removably coupled to said elongated member at saidproximal end portion; a tip secured to said elongated member andextending distally from said distal end portion, said tip being softerthan said distal end portion and being sized and configured so that saidtip comes in contact with the folded intraocular lens as said elongatedmember is moved distally in said hollow passage; and said elongatedmember includes a through hole and a portion of said tip is located insaid through hole, thereby facilitating permanent securement of said tipto said elongated member.
 2. The apparatus of claim 1 wherein said tipis more elastic than said distal end portion and is permanently securedto said elongated member.
 3. The apparatus of claim 1 wherein said tipis sized and configured so that at least a portion of said tip isintroduced into a fold of the folded intraocular lens as said elongatedmember is moved distally in said hollow passage.
 4. The apparatus ofclaim 1 wherein said tip is sized and configured so that at least aportion of said tip is held in a fold of the folded intraocular lens assaid elongated member is moved distally in said hollow passage.
 5. Theapparatus of claim 4 wherein said tip has a proximal end segment whichis longer than all the other segments of said tip combined and said tipis generally tapered in the distal direction.
 6. The apparatus of claim1 wherein said tip includes a proximal end region having a first outersurface defining a first cross-sectional area and a distal end regionhaving a second outer surface defining a second cross-sectional areasmaller than said first cross-sectional area.
 7. The apparatus of claim1 wherein said distal end region of said rod is interference fitted tosaid elongated member.
 8. The apparatus of claim 1 wherein said distalend region of said rod is threaded and said elongated member includesthreads which matingly engage said distal end region.
 9. An apparatusfor inserting a folded intraocular lens into an eye comprising:a tubedefining a hollow passage and having a port through which theintraocular lens is passed from said hollow passage into an eye; anelongated member longitudinally movable within said hollow passage andhaving a distal end portion and a proximal end portion; a rod which islongitudinally movable and has a distal end region which is removablycoupled to said elongated member at said proximal end portion; a tipsecured to said elongated member and extending distally from said distalend portion, said tip being softer than said distal end portion andbeing sized and configured so that said tip comes in contact with thefolded intraocular lens as said elongated member is moved distally insaid hollow passage; and said elongated member includes a plurality ofspaced-apart elements defining a cavity in which said distal end portionof said rod is maintained.
 10. The apparatus of claim 9 wherein saidplurality of spaced apart elements and said distal end region areconfigured to facilitate said distal end region passing into said cavityas said rod is moved longitudinally toward said elongated member and toresist said distal end region passing out of said cavity as said rod ismoved longitudinally away from said elongated member.
 11. The apparatusof claim 9 wherein said plurality of spaced apart elements are adaptedto flex as said distal end region is passed distally into said cavity.12. The apparatus of claim 9 wherein said distal end region of said rodis interference fitted into said cavity.
 13. An apparatus for holding afolded intraocular lens prior to insertion in an eye comprising:a tubedefining a hollow space in which a folded intraocular lens is maintainedprior to insertion in an eye, said tube having a port through which theintraocular lens is passed from said hollow passage into an eye; and atip holder positioned proximally of said hollow space and adapted tohold a tip prior to the tip being carried by a rod which islongitudinally movable within said hollow space.
 14. The apparatus ofclaim 13 wherein said tip holder defines a through space substantiallyaligned with said hollow space and through which the rod passes prior toentering into said hollow space.
 15. The apparatus of claim 14 whereinsaid tip holder is adapted to resist the tip separating from said tipholder as the rod is moved distally in said through space.
 16. Theapparatus of claim 14 wherein said tip holder is adapted to facilitatethe removal of the tip from the rod as the rod is moved proximally fromsaid hollow space.
 17. The apparatus of claim 15 wherein said tip holderincludes a lip extending into said through space.
 18. The apparatus ofclaim 13 wherein the combination of said tube and said tip holder is anintegral structure.
 19. The apparatus of claim 13 which furthercomprises a tip held by said tip holder, said tip being sized andconfigured so that at least a portion of said tip comes into contactwith the folded intraocular lens as the rod is moved longitudinallywithin the hollow space.
 20. A method for inserting an intraocular lensinto an eye comprising:placing an intraocular lens in a folded conditionin the apparatus of claim 19; moving a rod distally relative to said tipholder to position said tip on said rod; moving said rod furtherdistally into said hollow space thereby contacting said tip and saidintraocular lens; positioning said port in proximity to or in said eye;passing said intraocular lens through said hollow space, through saidport and into said eye; passing said rod proximally; and removing saidtip from said rod.